# K233191: TotalTi ACDF by SAGICO

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Analytics & Geometrical Implant Co, LLC
- Decided: Nov 21, 2023 after 54 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K841189 (1984). 223 ancestors in all.
No later device cites it as a predicate yet.
1 of 224 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221138: Titus Titanium Cervical by SAGICO, Sagico VA USA, LLC (2023) Summary page 5.
- K161710: Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion Cervical, Spinal Analytics & Geometrical Impant Co, LLC (2017) Summary page 5.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 5.
- K180401: TiWAVE-C™ Porous Titanium Cervical Cage, Kalitec Direct, LLC (2018) Summary page 5.

## Indications for use
The TotalTi ACDF by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The TotalTi ACDF by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The TotalTi ACDF by SAGICO is designed in a manner to be used with the additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

Source page: https://510kreport.com/device/K233191
Methodology: https://510kreport.com/methodology